In an industry where materials are globally sourced, qualifying the raw materials that go into producing a pharmaceutical product can be complex. Dave Backer, senior director and general manager at SAFC's Carlsbad, CA facility, and Mike Garrett, senior director, global marketing at BioReliance, spoke to BioPharm International about sourcing and risk mitigation for raw materials.

SOURCING RAW MATERIALS

BioPharm: It's now a global sourcing market for raw materials, presenting problems for manufacturers in ensuring a safe and secure supply chain. What industry initiatives are in place to ensure supply-chain quality?

Backer: SAFC is in the business of providing raw materials or services to the API market, both for small molecules and biologics. We recognize that there are two factors that have to be considered in the supply chain and for the raw materials that go into that supply chain. The first is: can the raw material be made correctly to begin with, and what does that mean? What is the level of quality of products that go into the supply chain? The reality is that some of these raw materials are made in large volumes for other industrial applications, of which the biologic or chemistry use is a small part of the total.

The second issue is where was it made? Determining where something is made is much more difficult than it sounds, and requires knowing, whatever that chemical is, that we've gone back to the source of manufacture and we've qualified that supplier. SAFC has initiated a program called PharmaGrade. It's a portfolio of products where we say that, for these products, we will confirm that we know exactly who the manufacturer is, that we've done quality audits, and that it's made appropriately for pharmaceutical manufacturing. There are other companies that are doing the same. EMD Millipore, for example, has the Emprove program, and some other companies are going down that path as well. For us as an industry, as suppliers, it becomes more evident that we have to hit a certain bar. Pharmaceutical and biotech companies are depending on suppliers to be able to provide them with products that are appropriate.